21 CFR Part 830Glossary

21 CFR Part 830 – Unique Device Identification (UDI)

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • UDI Master Data, Labeling & Traceability • Regulatory, QA/RA, Packaging, IT

21 CFR Part 830 establishes the United States Food & Drug Administration’s Unique Device Identification (UDI) system for medical devices. It requires a standardized identifier on device labels, packages, and—where applicable—directly on the device, and it mandates submission of device identification data to FDA’s Global UDI Database (GUDID). In practice, Part 830 connects regulatory master data, labeling controls, and downstream traceability. It works alongside device labeling rules in Part 801, quality system requirements (QMSR/Part 820), device tracking (Part 821), MDR reporting (Part 803), and corrections/removals (Part 806). A robust implementation integrates barcode standards, label verification, packaging hierarchies (SSCC on logistics units), and evidence in the DHR.

“UDI is the data backbone for device identity in the U.S.—a single truth that links the label in a clinician’s hand to the master data on file with FDA.”

TL;DR: Part 830 requires each device to bear a UDI composed of a fixed Device Identifier (DI) and variable Production Identifiers (PI) (lot/serial/expiry/manufacture date). The UDI appears in both AIDC (barcode) and HRI (readable text), with direct part marking for certain reprocessed/reused devices. Labelers must submit DI‑keyed attributes to GUDID. Use recognized issuing agencies (e.g., GS1, HIBCC, ICCBBA), govern labels via Document Control, verify barcodes with Label Verification, and maintain end‑to‑end links in Lot Genealogy and the DHR.

1) What Part 830 Covers—and What It Does Not

Covers: the structure of a UDI (DI/PI), the requirement to place UDI on the label/package and, when applicable, direct marking; use of FDA‑accredited issuing agencies; and submission of DI‑referenced device attributes to GUDID. It also establishes responsibilities for the “labeler” (typically the manufacturer) to create, maintain, and update identifiers and database entries across packaging levels.

Does not cover: Part 830 does not specify clinical performance, manufacturing process controls, or complaint handling—that’s the domain of QMSR/Part 820 and MDR/Part 803. Nor does it prescribe exact barcode symbologies per se (that flows from the chosen issuing agency standard). UDI is identity infrastructure; quality and safety controls still rely on your design controls, labeling SOPs, and production records.

2) Legal, System, and Data Integrity Anchors

UDI implementation is only as strong as its governance. Master data and label templates must be controlled under Document Control with effective dates, approvals, and change history. Electronic records need attribution and immutability consistent with 21 CFR Part 11 (where applicable) and validated interfaces under CSV. Packaging and distribution should align with GDP, and traceability should be demonstrable within the DHR and genealogy. Where GS1 is used, the DI commonly maps to the GTIN.

3) The Evidence Pack for UDI Compliance

Be audit‑ready with a coherent pack: the UDI assignment rules for each model and packaging level; label artwork and data carriers tied to effective specifications; barcode print quality and verification logs; a cross‑reference of DI to device attributes submitted to GUDID; procedures and records for direct part marking (if applicable); and integration evidence showing that the UDI in production and in the DHR matches the master data in the system of record. Where PIs are used (lot/serial/expiry/manufacture date), show that printing logic and scan validation are verified and contemporaneously recorded in execution systems (e.g., MES or packaging lines).

4) From Design to Distribution—A Standard UDI Path

1) Define the UDI strategy. Choose the issuing agency (e.g., GS1) and set DI assignment rules for device models and packaging levels. Create a governance SOP that ties UDI to part numbers and lifecycle states.
2) Master data & GUDID readiness. Build DI‑keyed attributes (brand, version/model, clinical size, MRI safety, sterilization, etc.) and map them to GUDID fields. Establish the submission process and stewardship roles.
3) Label design & verification. Create label templates with AIDC and HRI, include PI tokens, and lock them under document control. Validate printing, scanning, and verification at nominal and stress conditions.
4) Packaging execution. At pack, commission the label: print DI and PI, verify symbology and data content, and capture scan evidence in the DHR.
5) Aggregation & logistics. For cases/pallets, maintain identity continuity using logistics identifiers such as SSCC; keep parent‑child links for recalls and field actions.
6) Post‑market change control. When model or labeling changes occur, evaluate DI impacts and update GUDID and controlled labels via formal change control.

5) DI vs. PI—The Two Halves of a UDI

The Device Identifier (DI) is the fixed, primary key that identifies the labeler and the specific version or model of the device and its labeled package configuration. The Production Identifiers (PI)

6) AIDC, HRI & Label Quality

UDI must appear in both an AIDC data carrier (e.g., GS1‑128, GS1 DataMatrix) and in human‑readable interpretation (HRI). The data must be identical across both. Labels need legibility, durability, and correct placement. Use in‑line scanners to validate data content and symbology quality and capture verification results in batch/lot records. See Label Verification – Barcode & UDI Checks for practical controls.

7) Direct Part Marking (DPM)

Certain devices intended to be used more than once and reprocessed before each use require a directly marked UDI on the device itself. DPM methods (e.g., laser etch) must be validated for legibility and durability across the device’s intended life (cleaning, sterilization, wear). When space is constrained, the issuing agency standards provide rules for data carrier selection and formatting. The DHR should include DPM verification evidence for each lot or serial number range as appropriate.

8) Packaging Levels, Aggregation & Logistics

UDI applies to each relevant packaging level. A unit DI differs from a shelf carton DI; case‑level and higher logistics units can be identified with SSCC for handling and distribution. Maintain parent‑child relationships from unit to case to pallet in your WMS so partial recalls can be executed precisely without over‑pulling unaffected stock. Where EPCIS is used, publish commissioning and aggregation events to customers and distributors to strengthen end‑to‑end visibility.

9) GUDID—Submitting & Maintaining Master Data

GUDID is the public database keyed by DI. Labelers must submit and maintain accurate device attributes (e.g., brand name, version/model, device size, sterility, packaging configurations, and clinical characteristics). Treat GUDID like a regulated master data hub: establish stewardship roles, data quality checks, and change workflows that synchronize the DI, label templates, and ERP/MES/WMS item masters. If you retire a DI or change package levels, ensure downstream systems are updated concurrently to prevent UDI/packaging mismatches during production and shipping.

10) Change Control—When Does DI Change?

DI is a model‑level identifier; it changes when the version/model or package configuration changes in a way that affects identification. Manage DI changes under formal Management of Change, with impact assessment across labels, GUDID, bills of materials, IFUs, and the DHF/DHR. For variable data changes (e.g., expiry limit updates), ensure PI logic is updated, validated, and version‑controlled, and confirm that HRI and AIDC stay synchronized.

11) U.S.‑EU Alignment Considerations

While Part 830 is U.S.‑specific, many organizations harmonize with EU MDR’s UDI. The U.S. uses the DI/PI construct and GUDID; the EU uses UDI‑DI/UDI‑PI and introduces a Basic UDI‑DI concept (not used in the U.S.). To reduce complexity, implement one master data model that can populate both GUDID and EU databases, with clear mapping and governance. Keep label templates modular so regional differences (symbols, language, database access URLs) can be controlled without breaking the common identity logic.

12) Validation, Records & Part 11

Because UDI data flows through multiple systems—label management, PLM/ERP, MES, WMS, and submission tools—validate integrations and preserve audit trails. Electronic signatures and access controls should meet Part 11 expectations where used. Retain label proof, print logs, scanner verification, and GUDID submissions per your Record Retention & Archival SOP to support inspections and field actions.

13) Metrics That Demonstrate UDI Control

  • Label verification pass rate: % of labels meeting barcode quality and content checks at first pass.
  • DI–GUDID synchronization lag: median time from approved DI change to live GUDID update.
  • Scan readability in field returns: % of returned devices whose UDI scans successfully at intake.
  • Aggregation integrity: % of cases/pallets with complete and correct parent–child links.
  • UDI deviation rate: number of UDI‑related deviations per million labels printed.
  • Recall precision: % reduction in over‑recall quantities due to accurate UDI/aggregation data.

These indicators prove that identity is not just printed—it is governed, synchronized, and usable for real‑world traceability and recalls.

14) Common Pitfalls & How to Avoid Them

  • Unsynchronized masters. DI changes approved in PLM but not pushed to label templates or GUDID. Solve with a master‑data hub and automated checks.
  • HRI/AIDC mismatch. Human‑readable text doesn’t match the barcode. Enforce single‑source tokenization and end‑of‑line verification.
  • Weak DPM validation. Direct marks fade after reprocessing cycles. Validate durability across the device’s life.
  • Missing packaging level logic. Unit and carton share a DI unintentionally. Define distinct DIs per level and control aggregation.
  • Spreadsheet submissions. Manual GUDID updates drift from production truth. Use governed submissions with role‑based approval and reconciliation.
  • No linkage to DHR. Labels printed but not captured in the DHR. Integrate scanners and print logs into execution records.

15) What Belongs in the UDI Compliance Record

Include the issuing agency standard used; DI assignment rules and packaging hierarchy; approved label templates (with HRI examples and barcode specifications); print/scan verification evidence; direct part marking validation and inspection records; change controls affecting DI or label content; GUDID submissions and acknowledgements; and DHR excerpts showing UDI as‑produced. Cross‑reference to DHF (labeling design inputs/outputs) and to MOC for lifecycle traceability.

16) How This Fits with V5 by SG Systems Global

V5 Labeling & Master Data. The V5 platform centralizes DI assignment and label templates under Document Control. DI/PI tokenization is versioned, effective‑dated, and permissioned, preventing unsanctioned edits. V5 can map GS1 GTINs to internal part numbers and packaging hierarchies, so the same master drives printing across all sites.

V5 MES & Packaging Execution. The V5 MES binds label print events to lots/serials, enforces end‑of‑line label verification, and writes scan results into the DHR. If a verification fails, interlocks prevent release until reprint and re‑verification succeed.

V5 WMS & Aggregation. The V5 WMS preserves parent–child identity (unit → case → pallet) and applies SSCC at logistics levels. Where customers or distributors consume EPCIS, V5 can publish commissioning/aggregation events for downstream visibility.

V5 QMSR & Submissions Workflow. Within the V5 QMS, DI/label changes follow gated approvals with audit trails; submission packs for GUDID are generated from the same source of truth that drives printing—reducing DI drift. Dashboards track DI–GUDID synchronization, label verification pass rates, and recall precision.

Bottom line: V5 turns UDI into a governed data‑to‑label pipeline—what’s approved is what prints, what prints is verified, and what’s verified is captured in the DHR and synchronized to the outside world.

17) FAQ

Q1. Who is the “labeler” under Part 830?
The entity that causes the label to be applied to a device—commonly the manufacturer, but it could be a specification developer, repackager, or relabeler depending on the supply chain.

Q2. Do Class I devices need UDI?
Generally yes, but many enforcement policies and specific exceptions may apply. Regardless of class, treat DI/label governance the same so identity is consistent across your portfolio.

Q3. When must we use direct part marking?
When devices are intended to be used more than once and reprocessed before each use, unless an exception applies. Validate durability and include DPM checks in the DHR.

Q4. What changes require a new DI?
Changes to the version/model or package configuration that affect device identification generally require a new DI. Manage via formal change control and update GUDID and labels together.

Q5. Which barcode should we use?
Follow your issuing agency standard. With GS1, GS1 DataMatrix or GS1‑128 are common; ensure HRI mirrors the encoded data and that print quality meets verification criteria.

Q6. How does UDI help during recalls?
UDI enables precise, DI/PI‑based identification of affected units, supports where‑used queries, and reduces over‑recall by leveraging aggregation and logistics identifiers in WMS.

Related Reading
• UDI & Labeling: Label Verification | GS1 GTIN | Serialization
• Records & Quality: Device History Record (DHR) | Design History File (DHF) | Document Control | Record Retention
• Traceability & Logistics: Lot Genealogy | SSCC | EPCIS
• Adjacent FDA Parts: 21 CFR Part 820 (QMSR) | Part 803 (MDR) | Part 806 (Corrections & Removals) | Part 821 (Tracking)



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